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The Acumed Ankle Plating System contains orthopedic plates and lag screws intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula, particularly in osteopenic bone. The Acumed Small Fragment Base Set contains orthopedic plates and screws with the following indications: Acumed Hook Plates and Locking Peg Hook Plates are intended for fixation of fractures, osteotomies, and non-unions of small bones including the ulna, radius, tibia, and fibula. Acumed Fragment Plates and 4.0mm Cancellous Screws are intended for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small bones and small bone fragments. Acumed One-Third Tubular Plates are intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.

The Acumed Ankle and Small Fragment Base Set Update introduces new 2.7mm and 3.5mm variable angle screws for use with previously cleared plates from the Acumed Ankle Plating System (K143385) and Acumed Small Fragment Base Set (K143394). Additionally, this submission expands the Ankle Plating System to include use of existing 2.7mm and 3.5mm non-locking screws in independent bone fixation, for the K143385 indications.

The Acumed Ankle Plating System is intended for fixation of fractures, and non-unions of the distal tibia and fibula, particularly in osteopenic bone.

The Acumed Ankle Plating System consists of plates and accompanying screws implanted in the distal fibula and tibia. The plates are available in a variety of sizes and use a variety of screw sizes to accommodate varying patient anatomies and fracture patterns. All plates are anatomically pre-contoured, and are provided in left and right limb-specific options where applicable. All implants are manufactured from Ti-6Al-4V per ASTM F136 and provided both sterile and non-sterile. The system contains precontoured plates, 2.7, 3.5, and 4.0mm screws, syndesmosis targeting instrumentation, and other typical instrumentation for ankle plating cases.

The Acumed Small Bone IM Nail System is intended for fixation of fractures of the fibula, and ulna, including fractures where the medullary canal is narrow or flexibility of the implant is paramount.

The Acumed Small Bone IM Nail is a titanium alloy (Ti-6Al-4V) intramedullary rod/nail manufactured in multiple lengths (110mm to 270mm) and diameters (2.6mm to 4.0mm). The nails have openings used in conjunction with titanium alloy cortical screws, which lock them in place. The nails are compatible with an optional far-end locking (FEL) bushing and set screw that provide a locking option at the distal end of the nail. The nails are also compatible with optional end caps that thread into the proximal portion of the nail to provide additional length if desired. All implants are provided both sterile and non-sterile.

The Acumed Hand Plating System is intended for the management of fractures, fusions, and osteotomies of the distal, middle, and proximal phalanges and metacarpals and other bones of appropriate size for the devices.

The Hand Plating System consists of plates, locking screws, lag screws, and k-wires. Plates are available in a variety of shapes to accommodate varying fracture patterns and/or patient anatomy. The plates come in thicknesses of 0.8 mm to 1.3 mm. The locking screws have major thread diameters of 1.5 mm to 2.3 mm and are provided in lengths ranging from 5 mm to 20 mm. The lag screws have major thread diameters of 1.5 mm to 2.3 mm, provided in lengths ranging from 8 mm to 18 mm.The lag screws and k-wires are used for fixation. The plates are made of titanium per ASTM F-67. The screws, lag screws, and the kwires are made of titanium alloy per ASTM F136.

The Acumed Suture Anchor System is designed to be used for soft tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder. The Acumed Suture Anchor System is intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Shoulder: Rotator Cuff Repair, Bankhart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular shift or Capsulolabral Reconstruction. Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Foot/Ankle: Lateral Stabilization, Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar or Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

The Acumed Suture Anchor System is a system for anchoring soft tissue grafts), using #2 high-strength suture, back to the bone for reattachment. It is available in diameters of 4.5 mm & 5.5 mm in order to accommodate differing anatomic requirements. The anchor is a screw designed to provide fixation to bone that comes with two, #2 high-strength suture (pre-attached) in order to secure soft tissue (or soft tissue grafts) to the anchor. The system includes Class 1 instruments.

The Acumed Suture Anchor System is intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Shoulder: Rotator Cuff Repair, Bankhart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar or Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

The Acumed Suture Anchor System is a system for anchoring soft tissue (or soft tissue grafts), using #2 high-strength suture, back to the bone for reattachment. It is available in diameters of 3.5mm & 4.5mm in order to accommodate differing anatomic requirements. The anchor is a screw designed to provide fixation to bone that comes with two, #2 high-strength suture (pre-attached) in order to secure soft tissue (or soft tissue grafts) to the anchor. The system includes Class 1 instruments.